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U.S. Department of Health and Human Services

Class 2 Device Recall TITANIUM POWERPORT ISP IMPLANTED PORT WITH 6 FR CHRONOFLEX POLYURETHANE CATHETER

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 Class 2 Recall
TITANIUM POWERPORT ISP IMPLANTED PORT WITH 6 FR CHRONOFLEX POLYURETHANE CATHETER
see related information
Date Posted April 29, 2010
Recall Status1 Terminated on October 01, 2010
Recall Number Z-1525-2010
Recall Event ID 55175
Premarket Notification
510(K) Number
K072549 
Product Classification Port & Catheter, Implanted, Subcutaneous, Intravascular - Product Code LJT
Product PowerPort isp M.R.I Implanted Port without Suture Plugs with attachable 6F Chronoflex Polyurethane Open-ended Single -Lumen Venous Catheter, BARD Access Systems Assembled in Mexico Indicated for patient therapies requiring repeated access to the vascular system for the infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products and blood sample withdrawals.
Code Information REF#1806061 2 lots: Lot # RETE0854 and RETG1016
Recalling Firm/
Manufacturer
Bard Access Systems
605 North 5600 West
Salt Lake City, Utah 84116-3738
For Additional Information Contact BAS Customer Service
800-290-1689
Manufacturer Reason
for Recall
8F PowerPort stems were mixed with 6F PowerPorts and packaged.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Mix-Up of Materials/Components
Action The firm, Bard Access Systems, Inc. (BAS) sent a "URGENT: Powerport isp M.R.I with 6F Chronoflex Catheter RECALL" letter dated March 18, 2010, to the customers. The letter describes the product, problem and actions to be taken by customers. The customers were instructed to immediately examine their inventory and quarantine all products subject to this recall and notify any customers they may have distributed the product to; DO NOT USE THIS PRODUCT OR FURTHER DISTRIBUTE ANY OF THE IMPLICATED LOTS; remove and return the affected lots to BAS, and complete and Fax the Reply Form and Inventory Reconciliation Form, if unable to Fax call and report information. Only unused products, in its original packaging, should be returned to BAS. Should you have any questions or require assistance in this matter, please contact BAS Customer Service by calling our toll-free number 1-800-290-1689.
Quantity in Commerce 200 units total (100 units of each lot, see code information)
Distribution Nationwide distribution: AZ, CA, DC, FL, MA, MD, NC, NE, NV, NY, PA and SC.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LJT and Original Applicant = C.R. BARD, INC.
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